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Effect of Exercises on Ventilatory Function in Adult With TOF

ConditionsTetralogy of Fallot (TOF)Adults With Repaired Tetralogy of Fallot
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorCairo University

About this trial

The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:

* Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)? * Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?

Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.

Participants will:

On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week

On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week.

all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with TOF.

Have surgical correction of the abnormality.

Class II-III according to New York Heart Association (NYHA)

Ejection fracture > 40

Disqualifiers

Resent cardiopulmonary surgery or intervention "less than 6 months"

Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.

Mental or physical limitations

active infection or systemic illness.

Trial design

Design model

Parallel

Treatments tested in this trial

  • aerobic exercise

    Other intervention

    moderate intensity aerobic exercises on a treadmill: * Symptom-limited treadmill exercise training will be carried out at baseline for each participant following the modified Bruce protocol to estimate each participant's peak heart rate. * the target heart rate during training will be 50-60 % of each participant's heart rate reserve (moderate intensity exercise) * each session will have 5-10 min warm up, at least 20 min of moderate intensity aerobic exercise , and 5-10 min of cool down

  • respiratory muscle training

    Other intervention

    respiratory muscle training via threshold inspiratory muscle trainer (IMT) device: * maximum inspiratory effort will be detected for each participant as the maximum resistance at which the participant can efficiently achieve 10 breathing cycles, via (Threshold IMT device) * the training will be initiated with a low-intensity load (20-30%) of the participant's maximum inspiratory effort via (Threshold IMT device). Then, the intensity will increase gradually by 5% according to the participant's tolerance weekly until achieving 50% of maximum inspiratory effort. * the session will be formed of six sets, each set consisting of five deep breaths against the (Threshold IMT device), with a short interval of 1-2-minute rest between sets.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: combined respiratory muscle training and aerobic trainingExperimental treatment 2 interventions
Group B: aerobic exerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

"Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC).

Time frame
At Baseline and after 6 weeks of training

Secondary outcomes

1

Change from Baseline in Six-minute walk test (6MWT)

Time frame
At Baseline and after 6 weeks of training
2

changes from baseline in 36-Item Short Form Health Survey (SF-36)

as an assessment of quality of live

Time frame
at Baseline and after 6 weeks of training

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: